PolyPid Ltd. (Nasdaq: PYPD) announced that the FDA has accepted its New Drug Application (NDA) for D-PLEX₁₀₀ for the prevention of surgical site infections (SSIs) in abdominal colorectal surgery. The FDA granted Priority Review with a PDUFA goal date of November 28, 2026. The submission is supported by Phase 3 SHIELD II trial results showing a 60% relative risk reduction in SSIs. In July 2026, PolyPid entered an exclusive commercialization partnership with Azurity Pharmaceuticals for the U.S. and Canada. The deal includes $30 million in upfront and near-term milestones (already achieved upon NDA acceptance), with eligibility for up to $320 million in total milestones plus tiered royalties up to the mid-twenties. Azurity will also fund clinical development for potential label expansions. Financially, PolyPid reported a Q2 2026 net loss of $7.8 million. As of June 30, 2026, cash reserves were $6.6 million, which excludes the $30 million from Azurity. The company anticipates its current cash runway will extend into 2028. An MAA submission to the EMA is planned for Q3 2026.